Can a new inhaled COPD drug deliver the same effect with less body exposure?

NCT ID NCT07802730

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers are testing whether a new inhaled version of glycopyrrolate, called AERO-002, delivers the drug to the lungs with less of it entering the bloodstream compared to a standard inhaled glycopyrrolate product. The study enrolls healthy adults aged 18 to 55 who will receive a single dose of each product on separate occasions. The main goal is to measure how much of the drug reaches the blood and how quickly. This early-stage trial helps determine if the new formulation could offer a safer option for people with COPD.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AERO-002, an inhaled form of glycopyrrolate, compared with a standard inhaled glycopyrrolate product
What this could lead to
If AERO-002 delivers glycopyrrolate to the lungs with less drug entering the bloodstream, it could lead to a COPD treatment with fewer side effects.
What could go wrong
This is an early, small study in healthy people, not COPD patients. Differences in how the drug is absorbed may not translate to better outcomes or safety in real-world use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female aged 18 to 55 years, inclusive, at the time of informed consent * Forced expiratory volume in 1 second (FEV1) \> 80% of predicted normal at the Screening Visit (using the Global Lung Function Initiative \[GLI\] 2012 reference values) * Body mass index \> 18 and \< 32 kg/m2 at the Screening Visit * Able to abstain from alcohol for 24 hours prior to the Screening Visit, and prior to and after each dosing visit * Female participants of childbearing potential must not be pregnant, breast feeding, or lactating, and heterosexual female participants of childbearing potential must agree to use, with their partner, a male condom plus an approved method of highly effective birth control from the time of informed consent and for 30 days following the last administered dose * Female participants of childbearing potential must have a negative serum or urine pregnancy test at the Screening Visit and a negative urine pregnancy test prior to dosing at each Treatment Visit * Male participants who are sexually active with a female partner of childbearing potential must use, with their partner, a male condom plus an approved method of highly effective contraception from the time of informed consent and for 30 days following the last administered dose * Participants must agree not to donate semen or ova/oocytes from the time of informed consent and for 30 days following the last administered dose * Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments at the time of screening, as judged by the Investigator * Willing and able to provide written informed consent Exclusion Criteria: * Any condition or abnormality (including medical history, clinical laboratory, ECG, physical examination, or vital sign abnormalities), current or past, that, in the opinion of the Investigator or Medical Monitor, would compromise the safety of the participant, or would interfere with or complicate study procedures or assessments * Lower respiratory tract infection within 6 weeks prior to the Screening Visit * History of malignancy of any organ system, except for localized skin cancers, within 5 years prior to the Screening Visit * Major surgery (requiring general anaesthesia) within 6 weeks prior to the Screening Visit, or planned surgery through the end of the study * Positive serum hepatitis B surface antigen (HbsAg), hepatitis C virus antibodies (HCV Ab) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at the Screening Visit * Chronic viral infection or immunodeficiency condition * History of any drug and/or alcohol abuse in the past 2 years prior to the Screening Visit * Current or previous use of tobacco, nicotine products, or e-cigarettes within 6 months prior to the Screening Visit through the End of Study Visit * Smoking history of \> 5 pack years * Positive urine cotinine test at the Screening Visit or prior to dosing at each Treatment Visit * Regular alcohol consumption in males \>21 units per week and females \>14 units per week * Positive urine drugs of abuse test and/or alcohol breath test at the Screening Visit or prior to dosing at each Treatment Visit that cannot be accounted for by concomitant medication, in the opinion of the Investigator * Donation of ≥ 450 mL of blood within 8 weeks of the Screening Visit * History of intolerance or hypersensitivity to any of the ingredients in the formulation for AERO-002 or other aerosol medications * Participation in another investigational drug study within 30 days of the last dose, 5 average terminal elimination half-lives (T1/2) or twice the duration of the biological effect, whichever is longer, prior to the Screening Visit * History or high risk of noncompliance with study visits and procedures or unsuitable for entry into the study, at the discretion of the Investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Medicines Evaluation Unit Ltd

    Manchester, United Kingdom

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